CAPA Manager

Edwards Lifesciences • Salt Lake City, UT

1d

About The Position

The CAPA Manager leads and continuously improves the Corrective and Preventive Action (CAPA) program in a regulated medical device environment. The role owns the CAPA process governance framework, oversees execution, drives timely resolution of quality issues, facilitates robust investigations and root cause analysis, and partners with cross-functional teams to prevent recurrence of nonconformances. The CAPA Manager ensures CAPAs are managed from initiation through verification of effectiveness while fostering accountability, continuous improvement, and patient-focused quality.

The position serves as a site-wide or large-scope CAPA owner, collaborating across functions to align teams and drive actions affecting multiple groups. It may also lead and develop quality analysts, quality engineers, or CAPA coordinators. Other incidental duties may be assigned by Leadership.

Requirements

• Bachelor's degree with six (6) years of relevant experience, or equivalent work experience based on Edwards criteria.
• Proven experience leading, owning, and driving Corrective and Preventive Actions (CAPAs) within a regulated industry environment.
• Experience working in a highly regulated industry, such as medical devices, pharmaceuticals, biotechnology, aerospace, automotive, semiconductor, or other regulated manufacturing environments.

Nice To Haves

• Engineering or scientific degree.
• Medical device industry experience.
• Experience serving as a CAPA process owner, governance lead, or quality systems subject matter expert.
• Experience developing and managing CAPA governance frameworks, including performance metrics, review boards, escalation processes, and effectiveness verification programs.
• Experience driving enterprise-wide quality system improvements with measurable results in compliance, CAPA timeliness, recurrence reduction, or overall quality system effectiveness.
• Strong knowledge of quality management systems, root cause analysis methodologies, and structured problem-solving techniques.
• Experience conducting and reviewing investigations, identifying systemic root causes, and implementing sustainable corrective actions.
• Experience using quality metrics and data analysis to drive process improvements and operational effectiveness.
• Experience developing quality dashboards, trend analyses, and executive-level performance reporting.
• Knowledge of risk management methodologies and their application within CAPA investigations and corrective action planning.
• Strong project management experience leading complex cross-functional initiatives involving Quality, Manufacturing, Regulatory Affairs, Engineering, and Operations stakeholders.
• Lean, Six Sigma, or other continuous improvement certification and demonstrated application of continuous improvement tools.
• Demonstrated ability to lead teams, mentor stakeholders, and drive continuous improvement initiatives.
• Experience leading, coaching, or developing Quality Engineers, Quality Analysts, CAPA Coordinators, or other quality professionals.
• ASQ certification such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent.
• Experience working within medical device quality systems governed by FDA Quality System Regulation (21 CFR Part 820/QMSR), ISO 13485, EU MDR, and/or MDSAP requirements.

Responsibilities

• Own and maintain the CAPA process governance framework, including governance, metrics, escalation pathways, performance standards, review boards, and risk-based prioritization.
• Oversee Quality Systems CAPAs from initiation through investigation, risk assessment, action planning, implementation, verification of effectiveness, tracking, and closure.
• Coach and lead teams in structured problem-solving and root cause analysis tools; review investigations to ensure root causes are evidence-based, distinguished from symptoms, and addressed through systemic corrective actions.
• Ensure compliance with applicable FDA QSR/QMSR (21 CFR 820), ISO 13485, EU MDR, MDSAP, global regulatory requirements, and internal quality procedures related to CAPA.
• Develop and maintain CAPA dashboards, analyze performance trends, communicate performance and escalation needs, and drive measurable improvements in timeliness, recurrence reduction, closure quality, and effectiveness verification.
• Partner with cross-functional stakeholders to build accountability, gain buy-in for systemic corrective actions, facilitate alignment, and drive prevention-focused quality improvements.
• Lead and develop quality analysts, quality engineers, or CAPA coordinators as applicable, including coaching on quality systems, investigations, regulatory expectations, and talent development.
• Serve as the site-wide or large-scope CAPA owner and collaborate cross-functionally to facilitate alignment and drive actions that impact multiple teams.
• Perform other incidental duties assigned by Leadership.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager